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Publish all clinical trials, say pharma doctors

pharmafile | August 29, 2014 | News story | Research and Development, Sales and Marketing Goldacre, all trials, data, fpm, transparency 

All clinical trials should be registered and published according to a recent survey conducted by the Faculty of Pharmaceutical Medicine.

Out of the 400 Faculty of Pharmaceutical Medicine (FPM) members asked, nearly all (95%) suggested that trials should be registered, with 73% stating that clinical trials should be published within one to two years of completion.

The FPM, a part of the Royal College of Physicians, is made of doctors who hold a Diploma in Pharmaceutical Medicine. 

The results of the survey also reveal interesting notes on the state of clinical trial registries, including how to manage access to clinical trials data through an independent ‘gatekeeper.’

“I think the learnings from this survey will be most useful to all stakeholders as they continue to develop policies in these areas,” says Dr Keith Bragman, president of the FPM. 

“We cannot write evidence-based guidelines unless all trials are registered and the results published within a reasonable time frame upon completion of the trial.” 

It was also revealed that only 10% of the members asked believe that increased publication and dissemination of clinical trial results will harm pharma. Almost 90% judge that a greater scrutiny of clinical trial data will result in a stronger science base and enhance medical research.

Bragman adds: “We cannot satisfactorily answer questions unless we have access to results and data, whether positive or negative. We cannot educate those who are unaware unless we are first prepared to reveal, in a timely manner, the results of clinical trials.” 

This is an important issue for many in the medical profession, as unpublished clinical trials risk the possibility of research then being repeated unnecessarily. It can also distort results that doctors rely on to prescribe drugs safely and effectively to their patients. 

Earlier this year UK MPs published a report which called on the Department of Health to ensure that all clinical trials data are made available for treatments prescribed in the UK. And in April Europe took a decisive step toward forcing pharma to open up its clinical trial data when the EU Parliament passed new laws from 2016 to ensure that new trials are publicly registered with their results reported. 

When these new laws were announced Dr Ben Goldacre, author of Bad Pharma and co-founder of trial transparency lobby group AllTrials, praised the positive step forward but was wary that this only relates to new trials and medicines, not older ones that millions across the world are still using.

Goldacre who has been criticised by pharma for highlighting the worst examples of its practice and scaring the public, has been calling on the industry to publish full clinical data for all marketed drugs through the AllTrials campaign. 

Tom Robinson 

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